Approval Order StatementApproval for replacing the icad system's cad software with the second look cad software and increasing the system memory from 1 gigabyte to 2 gigabytes. The device, as modified, will be marketed under the trade name second look 200 and is indicated for: second look is a computed system intended to identify and mark regions of interest on standard mammographic views, including views from patients with breast implants and images from qualified full field digital mammography systems, to bring to the attention of the radiologist after the initial reading has been completed. Thus, the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review.